Managing Legacy Technology Security To help address the cybersecurity risks of legacy devices used in healthcare environments, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) has published “Health Industry Cybersecurity – Managing Legacy Technology Security (HIC-MaLTS).” The guide recommends cybersecurity strategies that manufacturers and health providers can implement for …
Risk Management Is More Than a Spreadsheet In a previous article, we discussed several causes that lead to product malfunctions and how to mitigate them. In this article, we will look at how a change from a document-driven risk management approach to a data-driven risk management approach can help mitigate product failure. Mitigating risk …
Contamination Control: Practical Steps to Compliance with EU GMP Annex 1 In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled by August 2023. The updated requirements, designed to protect …
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State-of-the-Art: Unpacking MDR’s Evolving Requirements The Oxford Dictionary defines “state-of-the-art” as something that belongs or relates to the most recent stage of technological development. It is something that incorporates the newest technology, ideas and features. In short, state-of-the-art means the most advanced, sophisticated, innovative version of a thing. The European Union’s Medical Device Regulation …
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